DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Declaration under 37 C.F.R. 1.132
2. The declaration under 37 CFR 1.132 filed 09/23/25, coupled to claim amendments made 09/23/25, is sufficient to overcome the rejection of claims 16, 19-20, 24, and 26-33 based upon (1) 35 U.S.C. 112(a) as failing to comply with the written description requirement; and (2) 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
Claim Status
3. The amendment(s) to claims and specification, filed 09/23/25, have been entered.
4. Claims 16-18, 21-23, 28-29, and 31-33 are pending. Claims 1-15, 19-20, 24-27, and 30 are cancelled. Claims 16, 28, 29, 32, and 33 are amended. Claims 17, 18, 21, 22, and 23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/30/25. Claims 16, 28-29, and 31-33 are under examination.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 06/23/25:
The objection to the specification for sequence compliance, found on page 2 at paragraph 4, is withdrawn in light of Applicant’s amendments thereto.
The rejection of claims 16, 19-20, 24, and 26-33 under 35 U.S.C. 112(b) as being indefinite, found on page 6 at paragraph 10, is withdrawn in light of Applicant’s amendments thereto or is moot in light of Applicant’s cancellation thereof.
The rejection of claims 16, 19-20, 24, and 26-33 under 35 U.S.C. 112(a) as failing to comply with the written description requirement, found on page 10 at paragraph 14, is withdrawn in light of Applicant’s amendments thereto coupled to the Declaration (see above).
The rejection of claims 16, 19-20, 24, and 26-33 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement, found on page 16 at paragraph 15, is withdrawn in light of Applicant’s amendments thereto coupled to the Declaration (see above).
Maintained: Objection to Specification
6. The use of the trade names and/or trademarks used in commerce, have been noted in this application (e.g. Amyris, Isobionics, Sigma, BASF, etc.). Where applicable, the term(s) should be accompanied by the generic terminology; and/or the term(s) should be capitalized wherever each appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Applicant’s Arguments and Response to Arguments
7. Applicant failed to correct or address this objection; therefore the objection is maintained for reasons of record.
Claim Interpretation
8. In the interest of compact prosecution, it is noted that:
Instant SEQ ID NO: 3 corresponds to marC from E. coli, as evidenced by:
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Even as amended, the only required structural limitations of the modified Escherichia coli in claim 16 encompass at least one of (1) the absence, inactivation or reduced abundance of the protein of SEQ ID NO: 3; or (2) a knock-out or a deletion, in part or full, of the gene encoding for the protein of SEQ ID NO: 3.
Improved tolerance to terpene compounds in general, and isoprenol and prenol in particular, is interpreted as a functional property; see MPEP 2112.01.
New Claim Objections
9. Newly amended claim 16 is objected to because of the following informalities: improper recitation of species names. Latin names of microorganisms are properly recited with the genus name (i.e. first part of binomial identifier) capitalized and species name (i.e. second part of binomial identifier) in lower case, with both in italics, and having the genus name spelled out upon first usage, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves). Thus, for example, “E. coli” is properly written as “Escherichia coli” upon its first usage and then “E. coli” subsequently). Appropriate correction is required.
Maintained Rejection: Claim Rejections - 35 USC § 112
10. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
11. Claims 28, 29, 32 and 33 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As amended, claim 16 is drawn to a modified Escherichia coli organism and requires the absence, inactivation or reduce abundance of the protein of SEQ ID NO: 3; and/or a knock-out or a deletion in part or full of the gene encoding for the protein of SEQ ID NO: 3.
Claims 28, 29, 32 and 33 fail to further limit claim 16, because claim 16 is drawn to a modified organism and not a composition and/or combination of a modified organism and a terpene compound.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant’s Arguments and Response to Arguments
12. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that the claims set forth further qualifications as to the one or more terpenes to which the microorganism has increased tolerance (see Remarks, page 9); the Office notes that characteristics of the terpenes per se do not further limit the claims because the functional properties of the modified E. coli cannot be separated from the structural requirements of the E. coli (i.e. see MPEP 2112.01). Therefore, because the claims are drawn to a modified organism, and not a composition comprising the modified organism and terpenes, the characteristics of the terpenes do not further limit the modified organism per se and accordingly, it remains the Office’s position that the modified E. coli in claim 16 is structurally identical to the modified E. coli in claims 28, 29, 32 and 33. Consequently, dependent claims 28, 29, 32 and 33 fail to further limit the modified E. coli in claim 16.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Maintained Rejection: Claim Rejections - 35 USC § 102
13. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
14. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. Claims 16, 28-29, 32 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDermott et al. 2008 (The marC gene of Escherichia coli is not involved in multiple antibiotic resistance; Antimicrobial agents and Chemotherapy 52(1): 382-383).
McDermott teaches E. coli AG100 (i.e. an organism) genetically modified to replace the marC locus with a kanamycin cassette (i.e. is a marC gene deletion mutant; see page 382, right column, first paragraph; meeting limitations found in instant claims 16; see also MPEP 2112.01). McDermott teach the modified organism in the presence of terpene compounds (e.g. fusidic acid; see page 382, right column, first paragraph).
With regards to wherein the tolerance to the terpene compounds isoprenol and/or prenol is increased, in newly amended claim 16 (i.e. formerly dependent claims 26 and 27); and/or wherein the terpene compound has a log P value of 2.0, in dependent claim 28; and/or wherein the solubility in water of the terpene compound is at least 1.0 g/l, in dependent claim 29; and/or wherein the terpene compound has a log P value of 1.5 or less, in dependent claim 32; and/or wherein the solubility in water of the terpene compound is at least 1.5 g/l, in dependent claim 33; none of these limitations add any structural requirements to the modified E. coli organism per se and thus each have been interpreted as a functional properties thereof; see MPEP 2112.01.
Therefore, McDermott anticipates the invention, as claimed.
Applicant’s Arguments and Response to Arguments
16. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that tolerance to prenol or isoprenol is not disclosed in McDermott (see Remarks, page 11); the Office notes, “tolerance” to terpenes in general, and prenol and/or isoprenol in particular, is interpreted as a functional property based on the structural requirements. Thus, this argument is not persuasive because the only structural requirement of the modified E. coli of claim 16 encompasses a deletion of the marC gene (i.e. instant SEQ ID NO: 3), which McDermott explicitly teaches.
Further, MPEP 2112.01 states that “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Since the Patent Office does not have the facilities for examining and comparing the isoprenol and prenol tolerance of the claimed E. coli to the isoprenol and prenol tolerance of the similarly modified E. coli of the prior art reference, the burden is upon the Applicant to show a novel and/or unobvious distinction between the material structural and functional characteristics of the claimed modified E. coli with that of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Allowable Subject Matter
17. Claim 31 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
18. No claims are allowed at this time.
19. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
20. A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached on (571)-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
October 21, 2025